Kornimate/medical-research-clean huggingface dataset:
radiofrequency and exercise-based rehabilitation on symptoms associated with pelvic floor dysfunctions in breast cancer

Conditions: Breast Cancer; Genitourinary Syndrome; Radiofrequency; Physical Exercise

Summary: breast cancer has a high impact, affecting 2.3 million women worldwide in 2022. in spain, there were 40,203 new cases in 2023. in addition to the economic and social costs, patients suffer genitourinary dysfunctions due to cancer treatments. genitourinary menopausal syndrome (gus) affects 50% of menopausal women, with a higher prevalence in women with breast cancer. this study aims to compare the effectiveness of radiofrequency (rf) and pelvic floor muscle exercise (pfmt) in the treatment of pelvic dysfunction associated with gus in breast cancer patients. a randomised, double-blind clinical trial will be conducted in collaboration with the association of women affected by breast cancer of elche and region) and the ceu cardenal herrera university. women diagnosed with breast cancer and pelvic dysfunction will participate, divided into three groups: one will receive pfmt, one will receive rf and one will receive pfmt+rf therapy. both techniques are expected to improve the quality of life of patients, where rf could offer additional benefits due to its proven effectiveness in the treatment of vaginal dryness and dyspareunia. the expected results will contribute to more effective and less invasive treatment protocols. the project presented has the potential to positively impact the health and well-being of women with breast cancer, reducing the symptoms associated with the disease and its treatment, and improving their quality of life.


Eligibility criteria:
inclusion criteria: * women of legal age with a clinical history of breast cancer, who agree to participate in the study and who present pelvic dysfunction assessed by the pelvic floor distress inventory (pfdi20) ≥ 100 * women survivors of stage 1 and 2 breast cancer * a medical discharge was granted more than one year ago * a diagnosis of another type of cancer has not been made. exclusion criteria: * having performed pmft or received rf in the last 12 months * use of vaginal oestrogens in the last 6 months * systemic hormone therapy in the last 6 months * laser therapy in the last 6 months * absence of pelvic floor contraction according to the modified oxford scale * use of pacemaker * use of heart pacemaker, decompensated heart or metabolic diseases, cognitive deficits, peripheral or central neurological disorders, previous surgeries in the pelvic region, skin pathologies or wounds in the treatment area or presence of an active urinary tract and/or vaginal infection.
comparison of different drilling speed to classify bone quality by tactile sensation on a saw bone model

Conditions: Missing Teeth; Dental Implant

Summary: comparison of different drilling speed to classify bone quality by tactile sensation on a saw bone model

bone quality is one of the major factors influencing the dental implant survival rate. bone quality is believed to have effects on initial implant stability and success of osseointegration. different implant designs and surgical protocols were developed for improving the survival rate in different bone quality. although bone quality can be partly diagnosed by radiographic images, lots of experienced surgeons also evaluate bone quality with tactile sensation when they drill the bone. however, variations in evaluation of bone density maybe exist among different surgeons. the drilling speed also may have effect on the outcome of evaluation. for less experienced dentists, it is difficult to diagnose bone quality with tactile sensation in the beginning. the purpose of this study is to find proper drilling speed to classify bone quality by tactile sensation on a saw bone model. saw bones of variant densities are used as training \& testing materials. the proper drilling speed to distinguish different bone quality will be evaluated and offered to junior dentists for better implant treatment outcome.

Eligibility criteria:
inclusion criteria: * adult dentist, with license no more than 5 years * no clinical implant surgery experience or with experience less than 10 implants. exclusion criteria: -subject who couldn't hold the test procedure

Keywords: dental implant bone quality tactile sensation drilling speed
brilliant-sc: a study of the efficacy and safety of blisibimod administration in subjects with iga nephropathy

Conditions: IgA Nephropathy

Summary: the purpose of this study is to compare the effect of blisibimod plus standard of care versus placebo plus standard of care alone on the proportion of subjects achieving improvement in renal disease parameters.


Eligibility criteria:
inclusion criteria: * 18 years of age or older. * biopsy-proven iga nephropathy * proteinuria ≥ 2g/24hr or equivalent * receiving physician-directed optimized standard of care that includes acei and/or arb. * estimated glomerular filtration rate (egfr) \>40ml/min/1.73m2 exclusion criteria: * clinical or histologic evidence of non-iga-related glomerulonephritis * iga nephropathy with greater than 50% glomerulosclerosis or cortical scarring * meets egfr criteria * malignancy within past 5 years * known to be positive for hiv and/or positive at the screening visit for hepatitis b, or hepatitis c * liver disease * neutropenia * active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections * history of active tuberculosis or a history of tuberculosis infection * pregnant or nursing

Keywords: blisibimod iga nephropathy baff blys
local anesthetic wound infusion and functional recovery after colon surgery

Conditions: Colon Cancer; Inflammatory Bowel Diseases; Diverticulitis

Summary: this is a double blinded randomized controlled trial in patients undergoing colon open surgery. the purpose is to evaluate the effectiveness of two different analgesic techniques on functional recovery after surgery. twenty five patients will receive thoracic epidural analgesia plus patient controlled analgesia (pca) (epidural analgesia group) and 25 patients wound infiltration of local anesthetic plus pca (wound infusion group). hypothesis: the postoperative recovery of patients receiving local anesthetic wound infusion will be faster than patients receiving thoracic epidural analgesia. functional recovery, pain intensity, opioid consumption and side effects, length of hospital stay and biological markers of inflammation after surgery will be measured in both groups.

this is double blinded randomised study of patients undergoing colon open surgery. one group of patients will receive thoracic epidural analgesia plus patient controlled analgesia (pca) (epidural analgesia group) and the other group will receive infiltration of local anesthetic plus pca (wound infusion group). functional restoration, assessed by self-administered quality of life questionnaires (sf-36, champs, icfs) and 2 and 6 min walking test will be assessed in the two groups at 3 and 8 weeks after the surgery.

Eligibility criteria:
inclusion criteria: * patients undergoing elective open colon surgery exclusion criteria: * asa physical status 4 * history of: * hepatic failure (liver enzymes abnormally elevated) * renal failure (creatinine over 150 mmol/l) * cardiac failure * organ transplant * diabetes * morbid obesity (bmi \> 40 kg/m-2) * chronic use of opioids * allergy to local anaesthetics * history of seizure * contraindications to the insertion of epidural * inr \> 1.3, ptt \> 44 second, platelets \< 150.000 per microliter, * previous spinal surgery limiting the insertion) * inability to comprehend pain assessment
non-invasive biomarkers in prostate cancer disease management

Conditions: Prostate Cancer

Summary: this study is an observational retrospective/ prospective study with diagnosed low/intermediate risk (no-surgery) \& high risk (surgery) prostate cancer that are eligible and willing to undergo standard of care (soc) assessment, annually along with biopsies, bio-fluid collection. participants will obtain genomic and histological evaluation on their biopsied samples. study follows soc collection with additional body fluid collection (blood, urine). biopsy/surgery will not require additional sample collection


Eligibility criteria:
inclusion criteria: * prostate cancer patients who had received primary diagnosis at moffitt or outside the cancer center with available records (radiology, pathology, access to samples). * no-surgery (intermediate risk) group: patients diagnosed with pre-biopsy mpmri, blood plasma: the biopsy must consist of a pathological diagnosis with a gleason pattern score. * surgery (high risk) group: patients who had radical prostatectomy (rp) with (or with-out) mpmr imaging, bio fluids available for research will be accrued for this group. we follow the nccn recommendations for high-risk (unfavorable intermediate risk or high-risk) groups inclusion and follow-up criteria (58, 89, 90). * ≥ 4 ng/ml and ≤ 20 ng/ml and psa ≤ 10 ng/ml (for late disease), within 3 months of study enrollment. * age 35 through 85 years. * zubrod/ecog performance status \<2; * ability to understand and willingness to sign a written informed consent document. * patients who agree to have a multiparametric mri with targeted/template biopsy. * patients must agree to fill out the longitudinal psychosocial questionnaires assessing health related quality of life. * availability of bio-samples (blood plasma, urine) for exosomal, proteomic, genomic and pathology (h\&e slides, ihc slides). * quantity of bio-samples; blood, urine, tissue sections (including ffpe) for each region of interest. exclusion criteria: * subject is not a candidate for multiparametric mri with contrast. some reasons may include (but are not limited to): renal insufficiency, foreign body or pacemakers. * no prior pelvic radiotherapy * no prior surgery to the prostate, other than transurethral procedures for benign prostatic hyperplasia (e.g., transurethral resection, green light laser treatment) * no concurrent, active malignancy, other than non-metastatic skin cancer of any type, superficial bladder cancer, or early-stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma) or \> bilateral hip replacement.

Keywords: intermediate risk prostate cancer high risk prostate cancer
telehealth exercise platform to reduce frailty after bone marrow transplant

Conditions: Hematopoietic and Lymphoid Cell Neoplasm

Summary: this clinical trial studies the feasibility of implementing a telehealth exercise platform to reduce frailty in patients after bone marrow transplant. the exercise program uses a telehealth platform (e.g. smart phones, tablets or computers) to view pre-recorded exercise videos on coordination, posture, stretching, balance and resistance/aerobic training. physical activity may help to improve physical function, including frailty, after bone marrow transplant. information from this trial may help researchers design future telehealth exercise routines for treating people with cancer.

primary objective: i. determine the feasibility of the telehealth exercise program, as evaluated by participation and completion rates. secondary objective: i. explore the effects of the telehealth exercise program on physical functioning. outline: patients are randomized to 1 of 2 arms. arm a: patients participate in telehealth exercise sessions at home over 30 minutes with a trainer 3 days a week for 8 weeks (24 total sessions). arm b: patients maintain their normal activities of daily living for 8 weeks before participating in the telehealth exercise program as described in arm i.

Eligibility criteria:
inclusion criteria: * \>= 18 years of age at the time of study enrollment * \>= 2-years from hematopoietic cell transplantation (hct) and in clinical remission * identified as pre-frail or frail based on bone marrow transplant survivorship study (bmtss) questionnaire (i.e. clinically underweight, exhaustion, low energy expenditure, slow walking speed, and muscle weakness), with the presence of \>= 3/5 indices classified as frail and 2/5 indices classified as prefrail * able to understand and sign the informed consent document * physically able and willing to complete all study procedures * has access to the internet and a smartphone * english speaking exclusion criteria: * overt cardiovascular disease (e.g. myocardial infarction, stroke, angina) * contraindications to exercise (acute infectious disease, physical disability preventing safe performance \[assistive devices\], cognitive impairment or inability to cooperate) * participation in regular exercise (\> 60 minutes per week) * female who are pregnant or planning to become pregnant
phase i/iia dose-escalation clinical study of vac-3s

Conditions: HIV-1 Infection

Summary: the purpose of this trial is to evaluate the safety and immunogenicity of the therapeutic vaccine candidate vac-3s in hiv-1 infected patients under antiretroviral therapy (art) with undetectable viral loads.


Eligibility criteria:
inclusion criteria: * hiv-1 infected patient * age between 18 and 55 years * art (antiretroviral therapy) initiation 1 year ago * plasma hiv rna below 50 copies per ml on three sequential occasions including v-1 in the past 12 months * cd4 t cell count above or equal to 200 cells per mm3, * nadir cd4 t cell count above or equal to 100 cells per mm3, * contraception in women with child-bearing potential exclusion criteria: * any art change within a month preceding screening. * chronic active liver disease, hiv-hepatitis coinfection. * immunotherapy in the past year, immunosuppressive treatment within the past month. * history of auto-immune disease

Keywords: hiv-1 hiv immunotherapy active immunotherapy vaccine virulence innate immunity nk cells
amg 334 20160172 pediatric migraine pk study.

Conditions: Migraine

Summary: amg 334 20160172 pediatric migraine pk study.

an open-label, randomized, multiple-dose study to evaluate safety, tolerability, and pharmacokinetics of amg 334 in children and adolescents with migraine

Eligibility criteria:
inclusion criteria: * subject's legally acceptable representative has provided informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated. * male and female children and adolescents ≥ 6 and \<18 years of age upon entry into screening * diagnosis of migraines, with or without aura, according to the international classification of headache disorders (ichd 3rd edition, 2013) for at least 12 months prior to the study screening * frequency of migraine of ≥ 4 migraine days per month in each of the 3 months prior to the study screening period exclusion criteria: * currently receiving treatment in another investigational device or drug study * history of migraine with brainstem aura or hemiplegic migraine headache * medical history or other condition that compromises the ability of the subject or legally acceptable representative to give appropriate informed consent and/or assent * malignancy except non-melanoma skin cancers or cervical cancer in situ within the last 5 years. * presence of any clinical condition that in opinion of the investigator might increased the risk of subjects participating in the study.
registry of asthma characterization and recruitment 3 (racr3)

Conditions: Asthma

Summary: this is a multi-center, non-interventional registry to create and maintain a database of participants to serve as a recruitment source for current and future dait niaid-sponsored childhood asthma in urban settings (cause) studies.

protocol cause-02 racr3 is a multi-center, non-interventional registry to create and maintain a database of participants to serve as a recruitment source for current and future dait niaid-sponsored childhood asthma in urban settings (cause) studies. approximately 1,500 participants - of all ages, living in selected office of management and budget (omb) defined metropolitan statistical areas (msas) will be enrolled in the registry. the registry database will be generated with data gathered at a single core visit, followed by optional additional visits. the registry will include assessments of various asthma and allergy characteristics to achieve a more flexible, efficient, selective, and inclusive approach to participant recruitment while still following national guidelines to foster participant safety. cause investigators may invite children or adults without asthma or atopic diseases to participate in the registry as "healthy" controls; for validation of laboratory tests, study monitoring equipment, and/or procedures; or for site procedure training of study personnel for certification and quality assurance. participants may opt to withdraw their information or discontinue from the registry at any time, in person, by telephone, or in writing.

Eligibility criteria:
inclusion criteria: 1. participant is either: 1. at least 18 years old, willing and able to provide informed consent at the time of enrollment 2. under the age of 18, accompanied by a legal guardian who is willing and able to provide informed consent at the time of enrollment 2. participant has a primary place of residence within the office of management and budget (omb)-defined metropolitan statistical area (msa) exclusion criteria: 1. participant does not speak english or spanish and/or guardian does not speak english or spanish 2. participant does not have access to a phone, either personal or public, with regularity that could be used for scheduling and safety follow-up 3. past or current medical problems or findings from physical examination or laboratory testing, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may affect the quality or interpretation of the data obtained from the study participants who are pregnant or lactating will not be excluded or discontinued from the study, but will not undergo any procedures that are prohibited during pregnancy per the childhood asthma in urban settings 02 (cause-02) registry for asthma characterization and recruitment 3 (racr3) manual of procedures (mop)(e.g., allergen skin testing, spirometry) during the pregnancy. potential participants may be reassessed as outlined in the protocol cause-02 mop.

Keywords: asthma allergy cause racr
early progressive mobility in the cvicu: assessing current status

Conditions: Immobility and Weakness Associated With Long Intensive Care Unit Stays

Summary: the current study is proposed to assess the frequency and type of progressive mobility procedures currently performed in the cvicu the study will evaluate the type and frequency of progressive mobility orders, whether or not progressive mobility steps are being taken by the nursing teams, define what steps patients are receiving, and record time to first weight bearing. other outcome measures will be the days of required mechanical ventilation, and current icu length of stay and cost to treat.

this will be a descriptive 4 month study of standard care practice. patients who meet the inclusion / exclusion criteria for study will be enrolled (waiver of informed consent is requested) and followed for a maximum of 28 days. the type and frequency of progressive mobility orders, whether or not progressive mobility steps are being taken by the nursing teams, define what steps patients are receiving, and record time to first weight bearing will be recorded. weight bearing will be defined as standing for at least 1 minute. icu los, ventilator days will be assessed at icu discharge for study patients. barriers to pm procedures will also be assessed.

Eligibility criteria:
inclusion criteria: * patient is ≥ 18 years old. * patient has been admitted to the icu for less than 3 days prior to study enrollment * patients require mechanical ventilation for \>48 hours exclusion criteria: * mobilization is contraindicated by patient's condition. such as hip fractures or other injury that would impede standing posture. * patient weighs less than 70 pounds or more than 440 pounds * mobilization is contraindicated by patient's condition or physician's orders exist that prevent the patient from participating in the mobility protocol. * patient was unable to walk or stand without assistance prior to icu admission. * patient was cognitively unable to follow verbal commands prior to icu admission. * patients current diagnosis includes acute stroke with neurologic impairment * patient's current diagnosis includes drug overdose. * patient has "do not resuscitate" orders and/or is at an end stage terminal disease state. * patient requires a specialty bed or mattress.

Keywords: icu los progressive mobility deconditioning
assessment of the long-term safety and efficacy of bempedoic acid (clear harmony ole)

Conditions: Hypercholesterolemia; Atherosclerotic Cardiovascular Disease

Summary: the purpose of this study is to see if bempedoic acid (etc-1002) is safe and well-tolerated in patients with high cardiovascular risk and elevated ldl cholesterol that is not adequately controlled by their current therapy.


Eligibility criteria:
inclusion criteria: * successfully completed clear harmony (1002-040) parent study exclusion criteria: * experienced a treatment-related sae that led to study drug discontinuation in the clear harmony (1002-040) parent study. * medical condition requires lipid measurement and/or adjustment of background lipid-regulating therapy.

Keywords: hyperlipidemia cholesterol heterozygous familial hypercholesterolemia atherosclerotic cardiovascular disease ascvd hefh ldl